Are You Overlooking This Critical Component Of Bioprocess Facility Design?
Are You Overlooking This Critical Component Of Bioprocess Facility Design?

HEPA air supply must be ceiling-mounted with the proper diffusers to provide a laminar flowing air “blanket.” Computational fluid dynamics (CFD) should be used for key suites to calculate the coverage, direction, and velocity. CFD’s provide  images of air flow dynamics, demonstrating air contours that would only be available if one were to execute smoke studies. The most serious issue that CFDs can expose is called mid-room “swirl” where the high velocity of the supply causes the air stream to strike the floor, sweep up the resting particulates on the floor, and “bounce” up into a circulating vortex of particulates, never to be removed.  Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the fourth in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.

  • Best Practices For Maintaining A Blind In Biosimilar Clinical Trials
    Best Practices For Maintaining A Blind In Biosimilar Clinical Trials

    A more aggressive clinical timeline for biosimilars can get a candidate to market more quickly. But it also becomes more difficult to ensure that clinical trial personnel running biosimilar trials clearly understand their roles and responsibilities, especially when it comes to maintaining a blind. There are several things for sponsors to consider in order to ensure the right people in the trial remain blinded.

  • What Can Biosimilars Learn From The Hepatitis C Payer Battles?
    What Can Biosimilars Learn From The Hepatitis C Payer Battles?

    In December 2014, Express Scripts stunned the pharmaceutical industry when it added AbbVie's Viekira Pak hep C treatment to its 2015 formulary instead of Gilead's Harvoni because of pricing. However, as Steve Miller, CMO of Express Scripts, discussed at the World Biosimilar Congress USA, competitive prices are just the beginning of the commercialization journey.

  • Anti-TNF Biosimilars In Europe: What Matters Beyond Price?
    Anti-TNF Biosimilars In Europe: What Matters Beyond Price?

    The recent introduction in Europe of biosimilar anti-tumor necrosis factor (anti-TNF) drugs has attracted considerable attention. Much of the commentary to date has centered on price, but price tells only part of the story. Structural and perceptual differences have led to considerable heterogeneity in the levels of discounting, access, and uptake throughout and even within European markets.

  • How To Succeed At Biosimilar Commercialization
    How To Succeed At Biosimilar Commercialization

    Steve Miller, CMO of Express Scripts emphasizes several key points for biosimilar makers to keep in mind as they work to establish their commercialization strategy.

  • How Patients Will Approach Your Biosimilar
    How Patients Will Approach Your Biosimilar

    Patients’ concerns — though they are to be expected when a new type of treatment emerges — can prove difficult to identify with on the biosimilar manufacturing side. But these concerns are important to understand when approaching FDA AdComs.

  • Biobetters: How Much Competition Should Biosimilar Makers Expect?
    Biobetters: How Much Competition Should Biosimilar Makers Expect?

    In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?

  • Bioprocess Facility Design — Layout Rules And Configurations
    Bioprocess Facility Design — Layout Rules And Configurations

    The adoption of single-use systems (SUS) is allowing for a shift to smaller and more flexible facilities. This article explores modern facility design options and configurations, and best practices for building a facility around SUS process technology.

  • The Norwegian Biosimilar Phenomenon: From Biosimilar To “Biogeneric”
    The Norwegian Biosimilar Phenomenon: From Biosimilar To “Biogeneric”

    Following the recent Amgen and Sandoz FDA advisory committee meetings, which focused heavily on concerns about “non-medical switching,” Dr. Steiner Madsen’s often frank discussion on how switching contributed to biosimilar uptake in Norway provides reassurance and best practices for global biosimilar makers.

  • Biosimilars Pipeline Analysis: Many Products, More Competition Coming
    Biosimilars Pipeline Analysis: Many Products, More Competition Coming

    Our discussion of biosimilars in this article will center on developed-market GMP biosimilars. In the European market alone, biosimilars already are a multibillion-dollar business, and one that is rapidly growing.

More Biosimilar editorial...

BIOSIMILAR INSIGHTS

  • A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017

    The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.

  • Six Myths About Serialization

    The global countdown to serialization compliance is well underway. Early adopters, such as Turkey and Argentina, required serialization as early as 2010, and were followed by others such as India, China and Korea.  Over the next three years, many other major markets will require adherence to their own serialization requirements, including the United States and the European Union. Expect that by 2018, serialization mandates will govern most of world’s drug supply. Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  • Crystalomics: A Pathway Forward For Protein Crystallization

    Protein crystals have shown the potential to address many of the issues associated with high concentration/high viscosity solutions. While formulation and delivery challenges exist with crystallized formulations, they are not insurmountable. With access to the right level of expertise and experience, a company can manufacture its product using crystallization, thereby increasing patient compliance by offering an easier and faster form of drug delivery. 

  • Is your Complex Formulation Process Set Up for Success?

    This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes.

  • Combination Products Deliver Patient Compliance

    In this e-book, you’ll find insight and advice from some of the top experts at Phillips-Medisize who have experience navigating the intertwined pathways of the drug and medtech industries that ultimately bring combination products to market.

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